Composition of human synthetic urine

ABSTRACT

This invention relates to a novel comprehensive composition comprising the major inorganic salts, urea, organic compounds, organic ammonium salts, proteins and human immuglobins present in normal human urine formulated into unisex synthetic human urine.

CROSS REFERENCE TO RELATED APPLICATIONS

Non Applicable.

FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Non Applicable.

REFERENCES DISCLOSED;

U.S. Pat. No. 7,192,776

U.S. Pat. No. 7,011,940

U.S. Pat. No. 6,306,422

U.S. Pat. No. 5,489,281

U.S. Pat. No. 5,489,281

U.S. Pat. No. 4,146,644

U.S. Pat. No. 7,192,776

BACKGROUND OF THE INVENTION

This invention relates to a novel comprehensive composition comprisingthe major inorganic salts, urea, organic compounds, organic ammoniumsalts, proteins and human immuglobins present in normal human urineformulated into unisex synthetic human urine. The use of sodium azide asa preservative solution is also disclosed.

Urine tests are an important and useful diagnostic tool because they areeasily obtained and inexpensive. Urine provides important informationabout a number of physiological processes, including but not limited torenal disease, diabetes mellitus, hydration status, toxicology, and someliver diseases. Many people will have a routine urine examination uponadmission to a hospital, and many outpatient settings do routineanalyses as well.

Blood is filtered by the kidneys, producing urine to rid the body ofwastes and to regulate fluid and electrolyte balance. The normal adultproduces between 1.0 to 1.5 liters of urine daily. Enormous amounts offluids pass through the kidneys every day, as about a thousand liters ofblood need to pass through the kidneys to produce one liter of urine.

The nephron is the primary unit of the kidney that produces urine, andeach kidney has about one million nephrons. The nephron is composed ofthe glomerular capsule, the proximal convoluted tubule, the loop ofHenle, and the distal convoluted table, which empties into a collectingtubule. Every minute about 125 mL of blood is filtered by the glomerliin an adult male, slightly less in an adult female. The nephrons filterthe blood of electrolytes, glucose, water, and small proteins, most ofwhich is reabsorbed in the proximial tubule. Urine in the healthy personcontains 96% water and 4% solutes, primarily urea and sodium chloride.

Despite the ease of urine collection, many problems in the handling ofspecimens occur which will provide inaccurate results. Problems canoccur with the collection process, the handling of the urine specimen,or with urine testing. Most urine tests require a minimum of 10 cc ofurine. Urine is collected through several methods; catherization,clean-catch, first morning, and pediatric collection.

Urine specimens must be examined within two hours of collection to avoidbacterial contamination. Bacteria that are present within the urine atcollection will convert urea to ammonia, giving false alkaline readings.The alkalinity, in turn, leads to breakdown of casts and proteins. Toavoid these problems, urine should be immediately refrigerated if itcannot be analyzed within a two hour period.

The disclosed invention in the application is a synthetic urinecomposition containing all the major analogs of normal unisex humanurine.

In response for the need of a reliable source of comprehensivelybiologically complete standard human urine analog numerous attempts toformulate synthetic urine have been made. For example, U.S. Pat. No.6,306,422 to Batich et al. (table 3, col. 16, line 50 et seq.), U.S.Pat. No. 5,328,954 to Sarangapani (table 1, col. 9, line 29 et seq.),U.S. Pat. No. 5,489,281 to Watanabe et al. (col. 12, example 6), U.S.Pat. No. 4,146,644 to Griffith et al. (table 1, col. 10), and U.S. Pat.No. 7,192,776. However, none of these references address a compositionsimilar to unisex human urine with all its major constituents.

Further, all the references do not have all the desired composition ofhuman urine and fail to include compounds which are necessary for acomprehensive control for human urine in diagnostic testing methodsavailable to one ordinarily skilled in the art that include but are notlimited to human immunoglobins, mammalian derived sources of albumin,inorganic salts, organic compounds, and organic ammonium salts.

The invention disclosed in this application comprises a compositionsimilar to natural human unisex urine. The invention disclosed is usefulfor all manners of diagnostic testing of human urine where the use of acomprehensive composition is desired.

The invention disclosed in this application can be used in the followingincluding urinalysis, and standard diagnostic testing methods comprisingbut not limited to, toxicology, urinanlysis, 11-deoxycortisol,17-hydroxycorticosteriods, 17-ketosteroids, 4-pyrodoxic acid,5-hydroxyindoleacetic acid, 5-hydroxyproline, addis count, albumin,aldosterone, amino acids, arylsulfate A, Bence Jones Protein, Benedictstest, cyclic adenosine monophosphate, delta-aminolevulinic acid (ALA),dexamethasone suppression, dinitrophenylhydrazine, D-xylose absorption,ferric chloride, glucose, hemosiderin, hydroxyproline, indicant, ketonebodies, melanin, melanocyte-stimulating hormone, mucopolysaccharidesqualitiative, nitrate bacteria screen, osmolality, oxalate, phenistix,pregnanetriol, protein electrophoresis, schilling test, specificgravity, thiocyanate, toxicology screening, twenty four hour urine,urethral pressure profile, urinalysis, urine phosphate, urobilinogen,urine phospahate, urobilinogen, vitamins B, water deprivation, waterloading and xanthuric acid, and drug screens.

BRIEF SUMMARY OF THE INVENTION

This invention relates to a novel comprehensive composition comprisingthe major inorganic salts, urea, organic compounds, organic ammoniumsalts, proteins and human immunoglobins present in normal human urineformulated into a synthetic unisex human urine (table 1).

The invention disclosed in this application relates to analogs orcompositions of a unisex human synthetic urine. The disclosed inventionis useful for calibration standards for diagnostic tests, calibrationstandards for ELISA test, calibration standards for gas chromatography,liquid chromatography, or any other diagnostic test known to oneordinarily skilled in the art of biochemical, metabolite, or diagnostictesting. Further, this invention relates to a comprehensive analog ofhuman synthetic undisclosed in the prior art that is useful as anegative control in all previously disclosed methods of diagnostictesting.

The invention disclosed in the invention can be used in the followingmethods listed below as negative controls including but not limited tourinalysis, and standard diagnostic testing methods comprising but notlimited to, toxicology, urinalysis, 11-deoxycortisol,17-hydroxycorticosteriods, 17-ketosteroids, 4-pyrodoxic acid,5-hydroxyindoleacetic acid, 5-hydroxyproline, addis count, albumin,aldosterone, amino acids, arylsulfate A, Bence Jones Protein, Benedictstest, cyclic adenosine monophosphate, delta-aminolevulinic acid (ALA),dexamethasone suppression, dinitrophenylhydrazine, D-xylose absorption,ferric chloride, glucose, hemosiderin, hydroxyproline, indicant, ketonebodies, melanin, melanocyte-stimulating hormone, mucopolysaccharidesqualitative, nitrate bacteria screen, osmolality, oxalate, phenistix,pregnanetriol, protein electrophoresis, schilling test, specificgravity, thiocyanate, toxicology screening, twenty four hour urine,urethral pressure profile, urinalysis, urine phosphate, urobilinogen,urine phosphate, urobilinogen, vitamins B, water deprivation, waterloading and xanthuric acid and drug screening.

The invention discloses a range of concentrations as a preferredembodiment because natural unisex human urine displays ranges ofcompositions depending on sex of the individual, metabolism,environmental factors, diet, general health or illness and geneticfactors.

The invention comprises a p.H range between 4 and 10.

The invention comprises a specific gravity range between 1.008 and1.030.

The invention disclosed in this application comprises the preferredembodiments of table 1 of the invention and range of concentrations ofthe preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 discloses the preferred embodiments comprising the invention ofthe application in the preferred concentrations.

DETAILED DESCRIPTION OF THE INVENTION

A preferred embodiment of this invention comprises a novel compositioncomprising the major inorganic salts, urea, organic compounds, organicammonium salts, proteins and human immunoglobins present in normal humanurine formulated into a synthetic urine (FIG. 1).

A preferred embodiment of this invention disclosed comprises analogs orcompositions of a unisex human synthetic urine. The disclosed inventionis useful for calibration standards for diagnostic tests, calibrationstandards for ELISA test, calibration standards for gas chromatography,or any other diagnostic test known to one ordinarily skilled in the artof biochemical or metabolite testing. Further, this invention relates toa comprehensive analog of human synthetic undisclosed in the prior artthat is useful as a negative control in all previously disclosed methodsof diagnostic testing.

A preferred embodiment of this invention is the compositions use in thefollowing methods diagnostic test listed below as a negative control.Such diagnostic testing include but is not limited too toxicology,urinalysis, 11-deoxycortisol, 17-hydroxycorticosteriods,17-ketosteroids, 4-pyrodoxic acid, 5-hydroxyindoleacetic acid,5-hydroxyproline, addis count, albumin, aldosterone, amino acids,arylsulfate A, Bence Jones Protein, Benedicts test, cyclic adenosinemonophosphate, delta-aminolevulinic acid (ALA), dexamethasonesuppression, dinitrophenylhydrazine, D-xylose absorption, ferricchloride, glucose, hemosiderin, hydroxyproline, indicant, ketone bodies,melanin, melanocyte-stimulating hormone, mucopolysaccharidesqualitative, nitrate bacteria screen, osmolality, oxalate, phenistix,pregnanetriol, protein electrophoresis, schilling test, specificgravity, thiocyanate, toxicology screening, twenty four hour urine,urethral pressure profile, urinalysis, urine phosphate, urobilinogen,urine phosphate, urobilinogen, vitamins B, water deprivation, waterloading and xanthuric acid.

In another embodiment of this invention is it discloses a range ofconcentrations of the constituents of the composition as a preferredembodiment as natural unisex human urine displays ranges of compositionsdepending on sex of the individual, metabolism, environmental factors,diet, general health or illness and genetic factors.

In another embodiment the invention disclosed in this applicationcomprises the preferred embodiments of table 1 of the invention andrange of concentrations of the preferred embodiments.

In another embodiment the invention comprises the following compositiondissolved in reverse osmosis, distilled, tap or natural sources ofwater; Sodium Chloride (2000 to 10000 mg/L), Potassium Chloride(500-2500 mg/L), Potassium Sulfate (500 to 3000 mg/L), Magnesium Sulfate(100-2000 mg/L), Magnesium Carbonate (20-400 mg/L), PotassiumBicarbonate (100-1000 mg/L), Potassium Phosphate (20-400 mg/L), CalciumPhosphate (5-200 mg/L), Urea (1000-20000 mg/L), Uric Acid (20 2000mg/L), Creatinine (500-5000 mg/L), Uropepsin (20-1000 mg/L), Creatine(20-1000 mg/L), Glycine (20-1000 mg/L), Phenol (20-1000 mg/L), Histidine(20-1000 mg/L), Androsterone (20-1000 mg/L), 1 Mthylhistidine (20-1000mg/L), Imidazole (20-1000 mg/L), Glucose (0.01-100), Taurine (20-200mg/L), Cytosine (5-200 mg/L), Citrulline (5-200 mg/L), AminoisobutyricAcid (5-200 mg/L), Threonine (5-200 mg/L), Lysine (5-200 mg/L),Incloxysulfuric Acid (5-200 mg/L), m-Hydroxyhippuric Acid (5-200 mg/L),p Hydroxyphenyl [hydrocrylic acid] (5-200 mg/L), Inositol (5-200 mg/L),Urobilin (5-200 mg/L), Tyrosine (5-200 mg/L), Asparagine (5-200 mg/L),Urobilingen (5-200 mg/L), Ammonium Hippurate (500-3000 mg/L), AmmoniumCitrate (200-1500 mg/L), Ammonium Glucuronate (200-1500 mg/L), AmmoniumUrate (200-1500 mg/L), Ammonium Lactate (100-1000 mg/L), L-AmmoniumGlutamate (100-1000 mg/L), Ammonium Asparate (20-200 mg/L), AmmoniumFormate (20-200 mg/L), Ammonium Pyruvate (20-200 mg/L), Ammonium Oxalate(5-100 mg/L), Dopamine (0.5-10 mg/L), Epinephrine (0.01-1 mg/L),Metanephrine (0.01-1 mg/L), Norepinephrine (0.01-1 mg/L),Vanillymandelic Acid (0.1 to 10 mg/L), Cortisol (0.01-3 mg/L), MammalianDerived Albumin (0.1-50mg/L), Human Immunoglobin G (0.0001-1 mg/L),Human Immunoglobin D (0.0001-1 mg/L), Human Immunglobin A (0.0001-1mg/L), Riboflavin (0.01-10 mg/L), Sodium Azide (0.1-10 mg/L), andreverse osmosis, distilled, tap or natural sources of water at aconcentration greater or equal to 90% of the total mass of thecomposition.

In another embodiment the invention comprises a p.H range between 4 and10.

In another embodiment the invention comprises a specific gravity rangebetween 1.008 and 1.030.

1. (canceled)
 2. (canceled)
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 5. (canceled) 6.(canceled)
 7. The sterile composition comprising; Sodium Chloride,Potassium Chloride, Potassium Sulfate, Magnesium Sulfate, MagnesiumCarbonate, Potassium Bicarbonate, Potassium Phosphate, CalciumPhosphate, Urea, Uric Acid, Creatinine, Uropepsin, Creatine, Glycine,Phenol, Histidine, Androsterone, 1 Methylhistidine, Imidazole, Glucose,Taurine, Cytosine, Citrulline, Aminoisobutyric Acid, Threonine, Lysine,Incloxysulfuric Acid, m-Hydroxyhippuric Acid, p Hydroxyphenyl[hydrocrylic acid], Inositol, Urobilin, Tyrosine, Asparagine,Urobilingen, Ammonium Hippurate, Ammonium Citrate, Ammonium Glucuronate,Ammonium Urate, Ammonium Lactate, L-Ammonium Glutamate, AmmoniumAsparate, Ammonium Formate, Ammonium Pyruvate, Ammonium Oxalate,Dopamine, Epinephrine, Metanephrine, Norepinephrine, VanillymandelicAcid, Cortisol, Mammalian Derived Albumin, Human Immunoglobin G, HumanImmunoglobin D, Human Immunglobin A, Dye Agent, gallic acid,antimicrobial agent dissolved in water wherein solution is furthersterilized by exposure to ultra violet light, radiation, ethylene oxidetreatment, ozone treatment, colloidal silver, radiation, filtration,heat, or any other method of sterilization.
 8. The composition of claim1 comprising a pH range between 4 and
 10. 9. The composition of claim 1comprising a specific gravity range between 1.008 g/cm̂3 and 1.030 g/cm̂3.10. The sterile composition comprising; Sodium Chloride, PotassiumChloride, Potassium Sulfate, Magnesium Sulfate, Magnesium Carbonate,Potassium Bicarbonate, Potassium Phosphate, Calcium Phosphate, Urea,Uric Acid, Creatinine, Uropepsin, Creatine, Glycine, Phenol, Histidine,Androsterone, 1 Methylhistidine, Imidazole, Glucose, Taurine, Cytosine,Citrulline, Aminoisobutyric Acid, Threonine, Lysine, IncloxysulfuricAcid, m-Hydroxyhippuric Acid, p Hydroxyphenyl [hydrocrylic acid],Inositol, Urobilin, Tyrosine, Asparagine, Urobilingen, AmmoniumHippurate, Ammonium Citrate, Ammonium Glucuronate, Ammonium Urate,Ammonium Lactate, L-Ammonium Glutamate, Ammonium Asparate, AmmoniumFormate, Ammonium Pyruvate, Ammonium Oxalate, Dopamine, Epinephrine,Metanephrine, Norepinephrine, Vanillymandelic Acid, Cortisol, MammalianDerived Albumin, Human Immunoglobin G, Human Immunoglobin D, HumanImmunglobin A, Dye Agent, gallic acid, antimicrobial agent not dissolvedin water wherein composition is further sterilized by exposure to ultraviolet light, radiation, ethylene oxide treatment, ozone treatment,colloidal silver, radiation, filtration, heat, or any other method ofsterilization.
 11. The composition of claim 1 further comprisinggonadotropins, follicle stimulating hormone, lutenizing hormone,estrone, estradial, estriol, 2-Hydroxyestrogens,1,6α-Hydroxyestrone,4-Hydroxyestrone, 2-Methoxyestrone, 2-Methoxyestradiol, Pregnanediol,Testosterone, Androsterone, Etiocholanolone, Pregnanetriol, Cortisone,Cortisol, THE, 5a-THF, THF, l lb-hydroxyandrosterone, 11b-hydroxyetiocholanolone, THB, THA, 5a-androstanediol,5b-androstanediol, 5a-THB, Aldosterone, and human growth hormone. 12.The composition of claim 1 further comprising human biological matterincluding but not limited to mammalian red blood cells, mammalian whiteblood cells (leukocytes) and mammalian epithelial cells.
 13. Thecomposition of claim 1 further comprising mammalian hyaline, mammalianwaxy, mammalian granular, and mammalian red cell casts and mammalianwhite blood cell casts.
 14. The composition of claim 7 furthercomprising human biological matter including but not limited to redblood cells, white blood cells (leukocytes) and epithelial cells. 15.The composition of claim 7 further comprising hyaline, waxy, granular,and red and white blood cell casts.
 16. The composition of claim 7further comprising gonadotropins, follicle stimulating hormone,lutenizing hormone, estrone, estradial, estriol,2-Hydroxyestrogens,1,6α-Hydroxyestrone, 4-Hydroxyestrone,2-Methoxyestrone, 2-Methoxyestradiol, Pregnanediol, Testosterone,Androsterone, Etiocholanolone, Pregnanetriol, Cortisone, Cortisol, THE,5a-THF, THF, 11b-hydroxyandrosterone, 11b-hydroxyetiocholanolone, THB,THA, 5a-androstanediol, 5b-androstanediol, 5a-THB, Aldosterone, andhuman growth hormone.
 17. The composition of claim 7 comprising a pHrange between 4 and
 10. 18. The composition of claim 7 comprising aspecific gravity range between 1.008 g/cm̂3 and 1.030 g/cm̂3.
 19. Thecomposition of claim 1 wherein said composition is sterilized by meansof aseptic processing including but not limited to, exposure to ultraviolet light, radiation, ethylene oxide treatment, ozone treatment,colloidal silver, radiation, filtration, heat, or any other methods ofsterilization that is known in the art.
 20. The composition of claim 7wherein said composition is sterilized by means of aseptic processingincluding but not limited to, exposure to ultra violet light, radiation,ethylene oxide treatment, ozone treatment, colloidal silver, radiation,filtration, heat, or any other methods of sterilization that is known inthe art.
 21. The composition of claim 1 wherein said composition furthercomprises urobilin.